Clinical Trial

PIEZO-101 First-in-Human Safety and Proof-of-Concept Study

Not Yet Recruiting Early Phase 1
View on ClinicalTrials.gov →
Summary
The aim of this first-in-human clinical study is to explore the safety, tolerability, pharmacodynamics, and exploratory efficacy of PIEZO-101, an investigational plasmid DNA biostimulator that aims to restore expression of key proteins in the skin for extracellular matrix rejuvenation. PIEZO-101 is administered using an intradermal injection followed by localized electroporation using the investigational device Piezopen. This clinical trial will study safety and tolerability, pharmacodynamics using biopsies from the left knee, and exploratory efficacy using photography on the décolleté. Up to 8 participants may be enrolled to ensure 6 evaluable participants complete the study.
Trial Details
NCT Number NCT07671027
Lead Sponsor Piezo Therapeutics, Inc.
Conditions Skin Aging, Wrinkles in Decolletage, Wrinkles in Left Knee, Left Knee Skin Laxity, Décolleté Wrinkles
Enrollment 8 participants
Start Date 2026-09
Primary Completion 2027-08 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-06-26